[Federal Register: May 23, 2001 (Volume 66, Number 100)]
[Notices]
[Page 28527-28528]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my01-101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1497]
The Mammography Quality Standards Act Final Regulations Document
#4; Final Guidance for Industry and FDA; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``The Mammography Quality
Standards Act Final Regulations Document #4; Final Guidance for
Industry and FDA.'' The final regulations implementing the Mammography
Quality Standards Act of 1992 (the MQSA) became effective April 28,
1999. The final guidance document is intended to assist facilities and
their personnel to meet the MQSA final regulations.
DATES: Submit written comments at any time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``The Mammography Quality
Standards Act Final Regulations Document #4; Final Guidance for
Industry and FDA'' to the Division of Small Manufacturers Assistance
(HFZ-220), Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your
request, or fax your request to 301-443-8818. Submit written comments
concerning this guidance to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Comments should be identified with the docket number found in
brackets in the heading of this document. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
FOR FURTHER INFORMATION CONTACT: Charles A. Finder, Center for Devices
and Radiological Health (HFZ-240), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-594-3332.
SUPPLEMENTARY INFORMATION:
I. Background
The draft guidance document was issued for public comment in the
Federal Register of September 13, 2000 (65 FR 55265). The comment
period ended on December 13, 2000. The draft guidance was discussed
with the National Mammography Quality Assurance Advisory Committee at
the September 28, 2000, meeting. The final guidance document has been
modified from the original draft guidance to address the seven public
comments received. There were several clarifying changes made to the
document, particularly dealing with the issues of what constitutes a
``major repair'' and when the physicist must perform onsite
evaluations. Several decision tree flow diagrams were added to the
document to help clarify these issues. Overall, there were no major
substantive changes made to the document.
II. Significance of the Guidance
This guidance document represents the agency's current thinking on
the MQSA final regulations guidance. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the applicable statutes and regulations.
The agency has adopted the good guidance practices (GGPs)
regulation, which sets forth the agency's regulations for the
development, issuance, and use of guidance documents (21 CFR 10.115; 65
FR 56468, September 19, 2000). This guidance document is issued as a
level 1 guidance consistent with GGPs.
III. Electronic Access
In order to receive ``The Mammography Quality Standards Act Final
Regulations Document #4; Final Guidance for Industry and FDA'' via your
fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or
301-827-0111 from a touch-tone telephone. Press 1 to enter the system.
At the second voice prompt press 1 to order a document. Enter the
document number (1159) followed by the pound sign (#). Follow the
remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so using the Internet. CDRH maintains an entry on the Internet for easy
access to information including text, graphics, and files that may be
downloaded to a personal computer with Internet access. Updated on a
regular basis, the CDRH home page includes the civil money penalty
guidance documents package, device safety alerts, Federal Register
reprints, information on premarket submissions (including lists of
approved applications and manufacturers' addresses), small
manufacturers' assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH home page may be accessed at http://www.fda.gov/
cdrh. ``The Mammography Quality Standards Act Final Regulations
Document#4; Final Guidance for Industry and FDA'' will also be
available on CDRH's mammography Web site at http://www.fda.gov/cdrh/
mammography. Guidance documents are also available on the Dockets
Management Branch Web site at http://www.fda.gov.ohrms/dockets/
default.htm.
[[Page 28528]]
IV. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written comments regarding this guidance at any time.
Two copies of any comments are to be submitted, except that individuals
may submit one copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. The guidance
document and received comments are available for public examination in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: May 16, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 01-12909 Filed 5-22-01; 8:45 am]
BILLING CODE 4160-01-S